Pertussis (Whooping Cough)NCT05040802
Effectiveness of Adacel Vaccination in Pregnancy at Preventing Pertussis in Infants < 2 Months of Age in the United States
An observational study of Pertussis (Whooping Cough), run by Sanofi Pasteur, a Sanofi Company at 1 site in France.
Trial summary
The purpose of this study is to determine the effectiveness of Adacel against pertussis disease in infants < 2 months when administered during pregnancy following the current Advisory Committee on Immunization Practices (ACIP) recommendations, i.e., from 27 to 36 weeks of gestation, and 14 days or more before delivery. Read more about this study
- Who is it for?
- Ages 2 days to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Pertussis (Whooping Cough)
- What is being tested?
- Not applicable / dataset analysis
- Type of treatment
- Vaccines
- How many people
- 462 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2021to 4 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 days to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants between 2 days to < 2 months of age for whom a case of pertussis was reported to one of 6 Emerging Infection Program (EIP) network sites included in the original Skoff et al. study (in 2017) and their respective control infants, for the study period.
Who may be able to join
- Cases were included if they met the following inclusion criteria:
- Reported pertussis disease in the referenced EIP surveillance database
- Age greater than 2 days and younger than two months of age
- Resided in the catchment area on date of onset of their cough
- Born in a hospital in their state of residence
- ≥ 37 weeks of gestation at birth
Show all 17Show fewer
- Not adopted, in foster care or living in a residential care facility
- Completed maternal interview
- Completed infant and maternal information
- Controls were included if they met the following inclusion criteria:
- Age greater than 2 days and younger than 2 months of age on date of cough onset for the corresponding case infant
- Resided in the catchment area on date of cough onset for the corresponding case infant
- Born in a hospital in their state of residence
- ≥ 37 weeks of gestation at birth
- Not adopted, in foster care or living in a residential care facility
- Maternal interview completed
- Infant and maternal information complete
Who cannot join
- Cases were excluded if they met any of the following exclusion criteria:
- Vaccination status of the mother unknown
- Infants whose mothers were vaccinated with Boostrix or an unknown vaccine brand
- Controls were excluded if they met any of the following exclusion criteria:
- Vaccination status of the mother unknown
- A pertussis diagnosis prior to the cough onset date of the corresponding case infant
- Controls that were matched to Boostrix or an unknown brand cases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Adacel Vaccination in Pregnancy at Preventing Pertussis in Infants < 2 Months of Age in the United States (US)
The purpose of this study is to determine the effectiveness of Adacel against pertussis disease in infants < 2 months when administered during pregnancy following the current Advisory Committee on Immunization Practices (ACIP) recommendations, i.e., from 27 to 36 weeks of gestation, and 14 days or more before delivery.
Read the detailed description
The original study included cases recorded from 01 January 2011 through 31 December 2014, based on retrospective case-control methodology.
- Conditions
- Pertussis (Whooping Cough)
- Being tested
- Not applicable / dataset analysis
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable / dataset analysisOther
Not applicable / dataset analysis
| Study group | Role | What they receive |
|---|---|---|
| Pertussis Case Group | Infants between 2 days to less than 2 months of age for whom a case of pertussis was reported (laboratory confirmed pertussis, epidemiological linkage to a laboratory-confirmed case and/or clinically compatible illness) and who met case inclusion criteria.
This post-hoc analysis was limited to infants born of mothers vaccinated with Adacel or who did not receive any tetanus, diphtheria, and acellular pertussis (Tdap) vaccine. Receives: Other: Not applicable / dataset analysis | |
| Control Group | Infants born at the same hospital as the case-infant who were less than 2 months old on the case-infant's cough onset date, and who met control inclusion criteria.
This post-hoc analysis was limited to infants born of mothers vaccinated with Adacel or who did not receive any Tdap vaccine. Receives: Other: Not applicable / dataset analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pertussis cases in infants less than 2 months and matched controls
Vaccine effectiveness at preventing pertussis in infants less than 2 months of age was estimated using conditional logistic regression.
Measured: During the data collection period (from 01 January 2011 to 31 December 2014)
Secondary outcomes (1)
Number of pertussis cases requiring hospitalization in infants less than 2 months and matched controls
Vaccine effectiveness at preventing pertussis requiring hospitalization was estimated using conditional logistic regression
Measured: During the data collection period (from 01 January 2011 to 31 December 2014)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start2 Jun 2021
- Primary completion4 Oct 2021
- Study completion4 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pertussis (Whooping Cough)Studies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040802
- Sponsor's protocol ID
- TD500059
- Status last verified
- Apr 2022
- First submitted
- 7 Sep 2021
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Publications
Skoff TH, Blain AE, Watt J, Scherzinger K, McMahon M, Zansky SM, Kudish K, Cieslak PR, Lewis M, Shang N, Martin SW. Impact of the US Maternal Tetanus, Diphtheria, and Acellular Pertussis Vaccination Program on Preventing Pertussis in Infants <2 Months of Age: A Case-Control Evaluation. Clin Infect Dis. 2017 Nov 29;65(12):1977-1983. doi: 10.1093/cid/cix724.
PubMed 29028938Vargas-Zambrano JC, Clark LR, Johnson DR, Monfredo C, Pool V, Li L, Bouvet PE, Blangero Y, Macina D. Prenatal tetanus-diphtheria-acellular pertussis vaccine effectiveness at preventing infant pertussis. Vaccine. 2023 May 2;41(18):2968-2975. doi: 10.1016/j.vaccine.2023.03.048. Epub 2023 Apr 7.
PubMed 37032227
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Adacel Vaccination in Pregnancy at Preventing Pertussis in Infants < 2 Months of Age in the United States (US)
- ClinicalTrials.gov ID
- NCT05040802
- Acronym / sponsor ID
- TD500059
- Conditions
- Pertussis (Whooping Cough)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 4 Oct 2021 (actual)
- Study completion
- 4 Oct 2021 (actual)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness of Adacel against pertussis disease in infants < 2 months when administered during pregnancy following the current Advisory Committee on Immunization Practices (ACIP) recommendations, i.e., from 27 to 36 weeks of gestation, and 14 days or more before delivery.
Detailed description
The original study included cases recorded from 01 January 2011 through 31 December 2014, based on retrospective case-control methodology.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pertussis Case Group | – | Other: Not applicable / dataset analysisInfants between 2 days to less than 2 months of age for whom a case of pertussis was reported (laboratory confirmed pertussis, epidemiological linkage to a laboratory-confirmed case and/or clinically compatible illness) and who met case inclusion criteria. This post-hoc analysis was limited to infants born of mothers vaccinated with Adacel or who did not receive any tetanus, diphtheria, and acellular pertussis (Tdap) vaccine. |
| Control Group | – | Other: Not applicable / dataset analysisInfants born at the same hospital as the case-infant who were less than 2 months old on the case-infant's cough onset date, and who met control inclusion criteria. This post-hoc analysis was limited to infants born of mothers vaccinated with Adacel or who did not receive any Tdap vaccine. |
Who may qualify
- Ages
- 2 days to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants between 2 days to < 2 months of age for whom a case of pertussis was reported to one of 6 Emerging Infection Program (EIP) network sites included in the original Skoff et al. study (in 2017) and their respective control infants, for the study period.
Key inclusion criteria (17 listed)
- Reported pertussis disease in the referenced EIP surveillance database
- Age greater than 2 days and younger than two months of age
- Resided in the catchment area on date of onset of their cough
- Born in a hospital in their state of residence
- ≥ 37 weeks of gestation at birth
Key exclusion criteria (7 listed)
- Vaccination status of the mother unknown
- Infants whose mothers were vaccinated with Boostrix or an unknown vaccine brand
- Vaccination status of the mother unknown
- A pertussis diagnosis prior to the cough onset date of the corresponding case infant
- Controls that were matched to Boostrix or an unknown brand cases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable / dataset analysisNot applicable / dataset analysis | Other | Control Group, Pertussis Case Group |
Primary outcome
Number of pertussis cases in infants less than 2 months and matched controls
Time frame: During the data collection period (from 01 January 2011 to 31 December 2014)
Vaccine effectiveness at preventing pertussis in infants less than 2 months of age was estimated using conditional logistic regression.
1 secondary outcome
Number of pertussis cases requiring hospitalization in infants less than 2 months and matched controls
Time frame: During the data collection period (from 01 January 2011 to 31 December 2014)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Results publication: PubMed 29028938Skoff TH, Blain AE, Watt J, Scherzinger K, McMahon M, Zansky SM, Kudish K, Cieslak PR, Lewis M, Shang N, Martin SW. Impact of the US Maternal Tetanus, Diphtheria, and Acellular Pertussis Vaccination Program on Preventing Pertussis in Infants <2 Months of Age: A Case-Control Evaluation. Clin Infect Dis. 2017 Nov 29;65(12):1977-1983. doi: 10.1093/cid/cix724.
- Results publication: PubMed 37032227Vargas-Zambrano JC, Clark LR, Johnson DR, Monfredo C, Pool V, Li L, Bouvet PE, Blangero Y, Macina D. Prenatal tetanus-diphtheria-acellular pertussis vaccine effectiveness at preventing infant pertussis. Vaccine. 2023 May 2;41(18):2968-2975. doi: 10.1016/j.vaccine.2023.03.048. Epub 2023 Apr 7.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pertussis (Whooping Cough), run by Sanofi Pasteur, a Sanofi Company at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of pertussis cases in infants less than 2 months and matched controls (time frame: During the data collection period (from 01 January 2011 to 31 December 2014)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05040802, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.